Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Unresectable, metastatic, or recurrent disease Measurable or evaluable disease (phase I) Measurable disease (phase II) No known brain metastases Patients with previously treated brain metastases who are not currently receiving steroids and have a stable CT scan or MRI are eligible PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) INR no greater than 1.5 times ULN (unless currently receiving anticoagulant therapy) PT/PTT no greater than 1.5 times ULN (unless currently receiving anticoagulant therapy) Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction to compounds of similar chemical or biologic composition to fluorouracil or oxaliplatin No other concurrent uncontrolled medical condition that would preclude study participation No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No known history of degenerative facet disease during prior fluorouracil therapy No HIV-positive patients receiving combination antiretroviral therapy PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent epoetin alfa during course 1 No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent immunotherapy Chemotherapy At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior oxaliplatin No other concurrent chemotherapy Endocrine therapy See Disease Characteristics Radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery Not specified Other No prior oblimersen No other concurrent investigational agents No other concurrent antitumor therapy
Sites / Locations
- San Antonio Cancer Institute